NINDS CREATE Bio Development Track: Preclinical Development for Biotechnology Products and Biologics (U01 - Clinical Trial Optional) | PAR 18 542

Opportunity Information: Apply for PAR 18 542

The NINDS CREATE Bio Development Track: Preclinical Development for Biotechnology Products and Biologics (U01 - Clinical Trial Optional) is a National Institutes of Health (NIH) cooperative agreement funding opportunity designed to push promising biotechnology-based therapeutics for neurological disorders toward human testing. It specifically targets biologic and biotech modalities such as peptides, proteins, oligonucleotides, gene therapies, cell therapies, and other emerging therapeutic platforms that fall within the mission areas of the National Institute of Neurological Disorders and Stroke (NINDS). The program is aimed at bridging the gap between a strong preclinical therapeutic concept and the regulatory package needed to seek permission to begin clinical studies in people.

A key point of this opportunity is that it is not intended for early discovery or basic validation work. Applicants are expected to enter the program with an identified clinical candidate already in hand. That candidate should show properties consistent with real-world clinical development needs, including adequate bioactivity, stability, manufacturability, and bioavailability, along with convincing in vivo efficacy and/or target engagement data where appropriate. In other words, the FOA is geared toward teams that have already narrowed their work to a specific lead therapeutic and are prepared to do the rigorous, regulated development activities that come right before filing with the FDA.

The main scope of supported work is IND-enabling development. That generally means the set of studies and documentation required to support an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). While the FOA description does not list every study type, IND-enabling efforts commonly include activities like preclinical safety and toxicology planning and execution, pharmacology and biodistribution as needed, chemistry/manufacturing/control (CMC) development to ensure the therapeutic can be made consistently and at suitable quality, formulation and stability work, and any additional supporting studies needed to justify first-in-human dosing and monitoring. The program is structured so that by the end of the award period, a successful project should have achieved at least submission of an IND application to the FDA, making that submission a central milestone and endpoint.

In addition to preclinical work, the FOA allows for an optional clinical component: a small, delayed-onset first-in-human Phase I clinical trial. "Delayed-onset" signals that the clinical trial is not necessarily meant to start immediately at award initiation; instead, it can begin after key preclinical and regulatory readiness steps are completed, aligning the start of human testing with IND submission/clearance and other preparatory milestones. The clinical trial is described as optional, meaning an application can focus strictly on IND-enabling development, or it can propose a pathway that includes a limited Phase I study once the program reaches the appropriate stage.

This funding mechanism is a cooperative agreement (U01), which usually implies substantial NIH involvement compared with more investigator-directed grant mechanisms. In practical terms, cooperative agreements often include active programmatic input, coordination around milestones, and structured progress monitoring, reflecting the fact that translational product development is milestone-driven and must stay aligned with regulatory expectations.

The opportunity falls under the NIH and is categorized under Health (CFDA 93.853). The listed award ceiling is $1,500,000, and the original closing date shown in the source data is 2021-05-07, with the FOA originally created on 2017-12-20. Because NIH opportunities can be reissued or updated over time, applicants typically confirm the current status and active due dates in the live FOA record, but the summary here reflects the provided source information.

Eligibility is broad and includes many types of domestic institutions and organizations, as well as certain non-U.S. entities. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; Native American tribal governments (federally recognized); other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The FOA also explicitly calls out additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), historically Black colleges and universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, U.S. territories or possessions, and non-domestic (non-U.S.) entities (foreign organizations). This breadth is consistent with the translational nature of the program, which may involve academic labs, medical centers, nonprofits, and industry partners working toward a regulatory milestone.

Overall, this FOA is best viewed as a later-stage translational program for neurotherapeutics in biologic/biotech formats, with a clear expectation of a defined clinical candidate at entry and a defined regulatory deliverable at exit. The intended arc of a funded project is straightforward: take a well-supported biologic therapeutic candidate, complete the IND-enabling package (and optionally a small Phase I study), and reach the point where an IND has been submitted to the FDA, positioning the therapy for subsequent clinical development.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS CREATE Bio Development Track: Preclinical Development for Biotechnology Products and Biologics (U01 - Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853.
• This funding opportunity was created on 2017-12-20.
• Applicants must submit their applications by 2021-05-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $1,500,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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